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FDA Digs Deeper On “New Paradigm” To Expand Rx Switches

 
• By Carolyn B. Phenicie

The questions FDA poses for a March 22-23 hearing indicate the agency is delving into greater detail than in its previous discussions of alternative routes to access pharmaceutical treatments. FDA says decisions would be made case by case, but refers to treating conditions including high cholesterol, high blood pressure, migraines and asthma.

FDA will hold a public hearing on a “new paradigm” for drug approvals that “under conditions of safe use” will allow nonprescription access to some categories of Rx drugs for treating chronic conditions.

The questions on which FDA seeks input at the March 22 and 23 hearing in Silver Spring, Md., indicate the agency is delving into greater detail than in previous discussions...

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